A Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer
Data Collection
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
Study start date: August 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer. * Determine the toxicity profile of this regimen in these patients. Secondary * Determine the clinical activity of this regimen, in terms of reduction in tumor burden, in these patients. * Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen. OUTLINE: This is a nonrandomized, dose-escalation study of celecoxib. Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment beyond 2 courses at the investigator's discretion. Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) and biologically active dose (BAD) are determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The BAD is defined as the maximum decrease in the level of PGE\_2 where no DLT occurs. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 21-27 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIB or IV * Measurable disease * Progressive disease after at least 2 prior standard chemotherapy regimens OR refused standard chemotherapy * No active CNS metastases PATIENT CHARACTERISTICS: Age * 21 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 2.5 times upper limit of normal (ULN) * PT and/or PTT no greater than 1.5 times ULN Renal * Creatinine no greater than 2 mg/dL Cardiovascular * No New York Heart Association class III or IV cardiac disease * No myocardial infarction within the past year * No symptomatic ventricular arrhythmia * No symptomatic conduction abnormality Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior gastrointestinal ulceration, bleeding, or perforation * No hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or other reagents used in this study * No concurrent disease or medical condition that would preclude study treatment or compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy Endocrine therapy * More than 4 weeks since prior corticosteroids * No concurrent steroids (including chronic use) * Concurrent topical steroids allowed Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified Other * More than 4 weeks since prior non-cytotoxic investigational agents * More than 3 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs) * No prior cyclooxygenase-2 (COX-2) inhibitors for metastatic NSCLC * No prior epidermal growth factor receptor inhibitor for metastatic NSCLC * No concurrent COX-2 inhibitors * No concurrent NSAIDs * No concurrent fluconazole or lithium
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, United StatesOpen Jonsson Comprehensive Cancer Center at UCLA in Google Maps